Interventional systems and associated devices and methods

ABSTRACT

According to some embodiments, the present technology includes device for removing obstructive material from a blood vessel lumen. For example, the device can comprise an elongated member, a cutting portion carried by a distal region of the elongated member, and a capture portion carried by the distal region of the elongated member. The cutting portion can comprise a blade configured to separate at least a portion of the obstructive material from the blood vessel wall, and the capture portion can comprise a mesh structure configured to enmesh and/or capture at least a portion of the obstructive material.

CROSS-REFERENCE TO RELATED APPLICATION(S)

The present technology claims the benefit of priority to U.S.Provisional Application No. 63/200,495, filed Mar. 10, 2021, which isincorporated by reference herein in its entirety.

TECHNICAL FIELD

The present technology relates generally to interventional systems andassociated devices and methods.

BACKGROUND

Deep vein thrombosis (DVT) is a condition comprising a blood clot in adeep vein, usually a leg vein though they can also occur in arm veins.Symptoms include pain, swelling, tenderness, and/or discoloration in theaffected limb. If untreated, it can lead to worsening of symptoms andcomplications such as post-thrombotic syndrome with symptoms of chronicpain, swelling, and skin discoloration, or pulmonary embolism (PE), avery serious and life-threatening condition. Pharmacologic treatmentsinclude blood-thinning medications or thrombolytic drugs. More recently,percutaneous catheters have been developed for the more rapid removal ofclot to remove the blockage and prevent PE. These include catheterswhich can deliver thrombolytic agents to the site of the clot, in somecases in combination with aspiration and/or the disruption of the clotinto smaller pieces. Other catheters mechanically capture and removeclot without thrombolytic agents, thereby reducing the bleeding riskincurred by these drugs. An early example of this is the Fogarty BalloonThrombectomy catheter. More recent examples include the ClotTriever®(Inari Medical, Irvine, Calif.) and the ReVene® Thrombectomy Catheter(Vetex Medical, Galway, Ireland).

Unfortunately, many of these therapies have limited success for partialor full blockages caused by chronic thrombus (i.e., a thrombus over oneor two months old). As the clot remains in the limb over a period ofmonths, the initial thrombus transforms into a fibrin and/or collagenstructure which is tougher and more firmly adhered to the wall. Chronicthrombus may take the form of fibrous trabeculae or membranes stretchinginto and across the vein lumen (also known as venous synechiae).Further, the thrombus becomes more firmly attached to the wall.Catheter-based thrombolysis or thrombectomy devices have a lower successrate in removing these blockages. Venous synechiae may also preventoptimal treatment of venous obstruction by balloon angioplasty orstenting, as the fibrous structures prevent permanent stretching of thevessel wall. There is a need for an improved endovascular thrombectomydevice which is able to successfully remove chronic thrombus.

SUMMARY

The subject technology is illustrated, for example, according to variousaspects described below, including with reference to FIGS. 1-28B.Various examples of aspects of the subject technology are described asnumbered clauses (1, 2, 3, etc.) for convenience. These are provided asexamples and do not limit the subject technology.

-   -   1. A device for modifying and/or removing obstructive material        from a lumen of a blood vessel, the device comprising:        -   an elongated member having a proximal portion and a distal            portion configured to be intravascularly positioned at a            treatment site in a blood vessel adjacent obstructive            material;        -   a cutting portion disposed at the distal portion of the            elongated member, the cutting portion including a cutting            element, wherein the cutting portion has a collapsed,            low-profile state for delivery to the treatment site and a            deployed state for cutting obstructive material at the            treatment site, and wherein the cutting element extends            radially away from the longitudinal axis of the elongated            member in the deployed state; and        -   a capturing portion disposed at the distal portion of the            elongated member, wherein the capturing portion is            configured to collect obstructive material that has been            dislodged by the cutting portion.    -   2. The device of Clause 1, wherein the capturing portion is        positioned distal of the cutting portion along the elongated        member.    -   3. The device of Clause 1 or Clause 2, wherein the capturing        portion is self-expandable.    -   4. The device of any one of Clauses 1 to 3, wherein the        elongated member comprises a first elongated member and a second        elongated member, and wherein the cutting portion is disposed at        a distal portion of the first elongated member and the capturing        portion is disposed at a distal portion of the second elongated        member.    -   5. The device of Clause 4, wherein the first and second        elongated members are configured to rotate and/or translate        relative to one another.    -   6. The device of Clause 4 or Clause 5, wherein the second        elongated member is configured to be slidably disposed within a        lumen of the first elongated member.    -   7. The device of Clause 4 or Clause 5, wherein the first        elongated member is configured to be slidably disposed within a        lumen of the second elongated member.    -   8. The device of any one of Clauses 1 to 7, wherein the cutting        portion comprises a blade disposed along a portion of the        cutting element.    -   9. The device of Clause 8, wherein the blade is disposed along        only a proximally facing surface of the cutting element.    -   10. The device of any one of Clauses 1 to 9, wherein a cutting        edge of the cutting element is substantially linear.    -   11. The device of any one of Clauses 1 to 9, wherein the cutting        element wraps around a longitudinal axis of the shaft.    -   12. The device of any one of Clauses 1 to 9, wherein the cutting        element is a first cutting element and the device further        comprises a second cutting element that is configured to extend        radially away from the longitudinal axis of the elongated shaft        in the deployed state.    -   13. The device of Clause 12, wherein an angle between the first        and second cutting elements in the deployed state is less than        180 degrees.    -   14. The device of Clause 12, wherein an angle between the first        and second cutting elements in the deployed state is from about        135 degrees to about 180 degrees.    -   15. The device of any one of Clauses 1 to 14, wherein the        capturing portion and the cutting portion are independently        deployable.    -   16. The device of any one of Clauses 1 to 15, wherein the        capturing portion comprises has a closed distal end portion and        an open proximal end portion.    -   17. The device of any one of Clauses 1 to 16, wherein the        capturing portion comprises a mesh.    -   18. The device of any one of Clauses 1 to 17, wherein the        capturing portion has a first region comprising a braid and a        second region comprises a stent.    -   19. The device of any one of Clauses 1 to 18, wherein, in a        deployed state, the cutting element has a proximally facing        portion and a distally facing portion, and wherein a sharpened        edge of the cutting element is disposed along only the        proximally facing portion.    -   20. The device of any one of Clauses 1 to 18, wherein, in a        deployed state, the cutting element has a proximally facing        portion and a distally facing portion, and wherein a sharpened        edge of the cutting element is disposed along only the distally        facing portion.    -   21. A system for modifying and/or removing obstructive material        from a lumen of a blood vessel, the system comprising:        -   a first elongated member having a proximal portion and a            distal portion configured to be intravascularly positioned            at a treatment site in a blood vessel adjacent obstructive            material;        -   a second elongated member having a proximal portion and a            distal portion configured to be intravascularly positioned            at the treatment site;        -   a cutting portion disposed at the distal portion of the            first elongated member, the cutting portion including a            cutting element, wherein the cutting portion has a            collapsed, low-profile state for delivery to the treatment            site and a deployed state for cutting obstructive material            at the treatment site, and wherein the cutting element            extends radially away from the longitudinal axis of the            first elongated member in the deployed state; and        -   a capturing portion disposed at the distal portion of the            second elongated member, wherein the capturing portion is            configured to collect obstructive material that has been            dislodged by the cutting portion.    -   22. The system of Clause 21, wherein the second elongated member        is slidably disposed within a lumen of the first elongated        member.    -   23. The system of Clause 21, wherein the first elongated member        is slidably disposed within a lumen of the second elongated        member.    -   24. The system of any one of Clauses 21 to 23, wherein a distal        region of the cutting portion is axially fixed to the distal        portion of the second elongated member and a proximal region of        the cutting portion is configured to move axially along the        second elongated member.    -   25. The system of any one of Clauses 21 to 14, wherein, in a        deployed state, the cutting element has a proximally facing        portion and a distally facing portion, and wherein a sharpened        edge of the cutting element is disposed along only the        proximally facing portion.    -   26. The system of any one of Clauses 21 to 24, wherein, in a        deployed state, the cutting element has a proximally facing        portion and a distally facing portion, and wherein a sharpened        edge of the cutting element is disposed along only the distally        facing portion.    -   27. The system of any one of Clauses 21 to 26, further        comprising an introducer sheath, and wherein the first and        second elongated members are configured to be slidably disposed        in a lumen of the introducer sheath.    -   28. A device for modifying and/or removing obstructive material        from a lumen of a blood vessel, the system comprising:        -   a first elongated member having a proximal portion and a            distal portion configured to be intravascularly positioned            at a treatment site in a blood vessel adjacent obstructive            material, wherein the first elongated member defines a lumen            extending therethrough;        -   a second elongated member having a proximal portion and a            distal portion configured to be intravascularly positioned            at the treatment site, wherein the second elongated member            is configured to be rotatably disposed within the lumen of            the first elongated member;        -   a cutting element configured to cut obstructive material at            the treatment site, the cutting element having a proximal            end region at the distal portion of the first elongated            member and a distal end region at the distal portion of the            second elongated member, wherein rotation of the second            elongated member relative to the first elongated member, or            vice versa, causes the cutting element to expand away from a            longitudinal axis of the second elongated member.    -   29. The device of Clause 28, wherein the cutting element wraps        at least partially around the longitudinal axis of the second        elongated member as it extends between the first elongated        member and the second elongated member.    -   30. The device of Clause 28 or Clause 29, wherein the cutting        element is a ribbon.    -   31. The device of any one of Clauses 28 to 30, wherein the        cutting element has longitudinally extending edges, and wherein        one or both longitudinally extending edges are sharpened.    -   32. The device of any one of Clauses 28 to 30, wherein the        cutting element has a proximally facing longitudinal edge and a        distally facing longitudinal edge, and wherein only one of the        proximally facing or distally facing longitudinal edge is        sharpened.    -   33. The device of any one of Clauses 28 to 32, wherein the        cutting element is a first cutting element and the device        comprises a second cutting element.    -   34. The device of Clause 33, wherein the second cutting element        is positioned radially inwardly of the first cutting element.    -   35. The device of Clause 33, wherein the second cutting element        is positioned radially outwardly of the first cutting element.    -   36. The device of any one of Clauses 33 to 35, wherein the        second cutting element is substantially linear.    -   37. The device of any one of Clauses 33 to 35, wherein the        second cutting element wraps at least partially around the        longitudinal axis of the second elongated member.    -   38. The device of any one of Clauses 33 to 37, further        comprising a third elongated member positioned between the first        and second elongated members, and wherein the second cutting        element is at a distal portion of the third elongated member.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure.

FIG. 1 schematically depicts a treatment system configured in accordancewith several embodiments of the present technology.

FIG. 2 schematically depicts a distal portion of a treatment systemconfigured in accordance with several embodiments of the presenttechnology.

FIGS. 3A and 3B are top views of a treatment assembly configured inaccordance with several embodiments of the present technology, shown ina collapsed state and an expanded state, respectively.

FIG. 4 schematically depicts an end view of a cutting portion of atreatment assembly configured in accordance with several embodiments ofthe present technology, shown positioned in a blood vessel lumen in anexpanded state.

FIG. 5 is a side view of a treatment assembly configured in accordancewith several embodiments of the present technology, shown in an expandedstate.

FIGS. 6 and 7 are side views of a treatment assembly configured inaccordance with several embodiments of the present technology.

FIGS. 8 and 9A are side views of a treatment assembly configured inaccordance with several embodiments of the present technology, shown inan expanded state.

FIG. 9B is a side view of a treatment assembly configured in accordancewith several embodiments of the present technology, shown in a collapsedstate.

FIG. 10 is a side view of a treatment assembly configured in accordancewith several embodiments of the present technology.

FIG. 11 is a side view of a treatment assembly configured in accordancewith several embodiments of the present technology, shown in an expandedstate.

FIGS. 12A-12C are side views of a treatment system having a treatmentdevice and an introducer sheath with a proximal funnel configured inaccordance with several embodiments of the present technology.

FIGS. 13-16 are side view of capture portions configured in accordancewith several embodiments of the present technology.

FIG. 17A is an isometric view of a cutting portion configured inaccordance with the present technology, shown in an expanded state.

FIG. 17B is an end view of the cutting portion shown in FIG. 17A shownpositioned within a blood vessel lumen in an expanded state.

FIG. 18A is an isometric view of a cutting portion configured inaccordance with the present technology, shown in an expanded state.

FIG. 18B is an end view of the cutting portion shown in FIG. 18A shownpositioned within a blood vessel lumen in an expanded state.

FIG. 19A is an exploded view of a blade assembly configured inaccordance with several embodiments of the present technology.

FIG. 19B is an assembled view of a blade assembly configured inaccordance with several embodiments of the present technology.

FIGS. 20A and 20B are perspective views of a treatment assemblyconfigured in accordance with several embodiments of the presenttechnology, shown in a collapsed state and an expanded state,respectively.

FIGS. 21A and 21B are perspective views of a treatment assemblyconfigured in accordance with several embodiments of the presenttechnology, shown in a collapsed state and an expanded state,respectively.

FIGS. 22A, 22B, and 22C are perspective views of a treatment assemblyconfigured in accordance with several embodiments of the presenttechnology, shown with various components removed for ease ofexplanation.

FIGS. 23A and 23B perspective views of a treatment assembly configuredin accordance with several embodiments of the present technology, shownin a collapsed state and an expanded state, respectively.

FIG. 24 is a perspective view of a treatment assembly configured inaccordance with several embodiments of the present technology, shown inan expanded state.

FIG. 25 is a perspective view of a treatment assembly configured inaccordance with several embodiments of the present technology, shown inan expanded state.

FIG. 26 is a perspective view of a treatment assembly configured inaccordance with several embodiments of the present technology.

FIGS. 27A and 27B are isometric views of a cutting portion configured inaccordance with several embodiments of the present technology. FIG. 27Ashows the cutting portion in a collapsed state. FIG. 27B shows thecutting portion in an expanded state.

FIGS. 27C and 27D are side views of an arm of the cutting portion shownin FIGS. 27A and 27B, shown isolated from the treatment assembly andconfigured in accordance with several embodiments of the presenttechnology.

FIGS. 28A and 28B are isometric views of a cutting portion configured inaccordance with several embodiments of the present technology. FIG. 28Ashows the cutting portion in a collapsed state. FIG. 28B shows thecutting portion in an expanded state.

DETAILED DESCRIPTION

FIG. 1 schematically depicts a treatment system 10 (also referred toherein as “the system 10”) configured in accordance with the presenttechnology. The treatment system 10 is configured to access a body lumen(such as a vein or artery) and modify, capture, and/or removeobstructive material from the body lumen. As used herein, “obstruction”or “obstructive material” can comprise, for example, clot material,atherosclerotic plaque, and/or other flow-obstructing structures,including those derivative of clot material, such as fibrotic clotmaterial, venous synechiae, fibrinous structures, collagenousstructures, fibrous trabeculae, and/or others. As shown in FIG. 1, thesystem 10 may comprise a treatment device 101 (or “device 101”) having aproximal portion 101 a configured to be positioned extracorporeallyduring the procedure, a distal portion 101 b configured to be positionedat a treatment site within a blood vessel, and one or more elongatedmembers 102 extending between the proximal portion 101 a and the distalportion 101 b. The treatment device 101 can also include a handle 12 anda sleeve 112 extending distally from the handle 12. The elongated member102 can be configured to be slidably disposed within a lumen of thesleeve 112. In several embodiments, the treatment device 101 does notinclude one of the sleeve 112 or the elongated member 102. In these andother embodiments, the treatment device 101 includes two or moreelongated members (for example, as described herein with respect to FIG.2). The treatment device 101 may include a lumen 22 to accept aguidewire or other guide rail, so that the device 101 may be positionedover the guide to a treatment site. The lumen 22 may extend along theelongated member 102 (or any component thereof) and terminate distallyat a distal opening. The lumen 22 may also be configured to receive avisualization device therethrough.

The treatment device 101 further includes a treatment assembly 100 (or“assembly 100”) carried by a distal portion of the elongated member 102.The treatment assembly 100 can comprise a capture portion 200 and acutting portion 300, which may be integral with one another or separatecomponents. The cutting portion 300 can comprise one or more cuttingelements configured to cut through obstructive material in the vessellumen as the treatment assembly 100 is moved axially along the lumen,thereby separating and/or releasing obstructive material from the vesselwall and/or from other obstructive material. The capture portion 200 cancomprise one or more expandable mesh structures configured to engage,trap, or otherwise become enmeshed with obstructive material at thetreatment site, before, during, or after engagement by the cuttingportion 300. The capture portion 200 can comprise any of the captureportions 200 described herein, and the cutting portion 300 can compriseany of the cutting portions 300 described herein. Additional detailsregarding the capture portion 200 and the cutting portion 300 aredescribed below.

The treatment assembly 100 is transformable between a low-profile statefor delivery to the vessel lumen and a deployed (e.g., expanded) state,as detailed herein. As used herein with reference to the treatmentassembly 100, “expanded” and “deployed” refer to a configuration of thetreatment assembly 100 when one or both of the capture portion 200 andthe cutting portion 300 are in a partially or fully expanded state.According to several embodiments described herein, the capture portion200 and the cutting portion 300 are integrated into a single expandabledevice. In some of such embodiments, the treatment assembly 100 isself-expanding and coupled to a distal end portion of a single elongatedmember 102. In other embodiments in which the capture portion 200 andthe cutting portion 300 are integrated into a single expandable device,the treatment assembly 100 (regardless of whether the treatment assembly100 is self-expanding or requires activation) is coupled to at least twoelongated members 108, 111, as shown in FIG. 2. The sleeve 112 may bepositioned over the treatment assembly 100 to radially constrain and/orprotect the treatment assembly 100 while being introduced to the vessellumen. In such embodiments, the sleeve 112 is withdrawn proximally toexpose the treatment assembly 100 to allow one or more portions of thetreatment assembly 100 to expand.

According to several aspects of the technology, the capture portion 200and the cutting portion 300 are independently deployable. In suchembodiments, both the capture portion 200 and the cutting portion 300can be self-expanding and be coupled to the same elongated member 102 ormay be coupled to separate elongated members.

In some embodiments the capture portion 200 and the cutting portion 300comprise separately-formed components, both carried by the distal regionof the elongated member 102. One of many examples of such embodiments isshown in FIGS. 3A and 3B. In these embodiments, the capture portion 200and the cutting portion 300 can be configured to collapse and expandindependently of one another or via the same actuation mechanism. Forexample, the capture portion 200 can be a resilient structure configuredto self-expand upon withdrawal of a sleeve 112, while expansion of thecutting portion 300 may require an additional actuation step by theoperator (as detailed herein). Likewise, the cutting portion 300 can bea resilient structure configured to self-expand upon withdrawal of thesleeve 112, while expansion of the capture portion 200 may require anadditional actuation step by the operator (as detailed herein).According to some examples, both the capture portion 200 and cuttingportion 300 are resilient, self-expanding structures.

Referring still to FIG. 1, the handle 12 at the proximal portion 101 aof the treatment device 101 can be permanently or detachably coupled toone or more of the elongated members (such as the sleeve 112, theelongated member 102, the inner member 108, the outer member 111, etc.).The handle 12 can include one or more actuators for controlling movementof one or more portions of the treatment assembly 100. For example, thehandle 12 can include a first actuator 14 that is mechanically (e.g.,via a push rod, push tube, and/or pull-wire) and/or electrically (e.g.,via one or more wires) coupled to the capture portion 200 and a secondactuator 16 that is mechanically (e.g., via a push rod, push tube,and/or pull-wire) and/or electrically (e.g., via one or more wires)coupled to the cutting portion 300. Activation of the first actuator 14,for example, can control one or more movements of the capture portion200. In some embodiments, the first actuator 14 controls the axialmovement, rotational movement, and/or radial expansion/contraction ofsome or all of the capture portion 200. In some embodiments, the secondactuator 16 controls the axial movement, rotational movement, and/orradial expansion/contraction of some or all of the cutting portion 300.In some embodiments, the first actuator 14 controls the axial movement,rotational movement, and/or radial expansion/contraction of some or allof the capture portion 200. According to some aspects of the technology,the first and/or second actuators 14, 16 and/or a third actuator (notshown) controls the axial movement, rotational movement, and/or radialexpansion/contraction of some or all of the capture portion 200 and someor all of the cutting portion 300. For example, the handle 12 caninclude an actuator that is configured to move the cutting portion 300axially with respect to the capture portion 200 (or vice versa).

In some embodiments, the first and/or second actuator 14, 16, or anadditional actuator (not shown) at the handle 12 is coupled to thesleeve 112 and configured to control axial and/or rotational movement ofthe sleeve 112. Such an actuator, for example, can be configured toaxially advance or withdraw the sleeve 112 to selectively expose orcover all or a portion of the treatment assembly 100. In someembodiments, the first and/or second actuator 14, 16, or an additionalactuator (not shown) at the handle 12 is coupled to the elongated member102 and configured to control axial and/or rotational movement of theelongated member 102. In some embodiments, the first and/or secondactuator 14, 16, or an additional actuator (not shown) at the handle 12is coupled to the inner member 108 and configured to control axialand/or rotational movement of the inner member 108. In some embodiments,the first and/or second actuator 14, 16, or an additional actuator (notshown) at the handle 12 is coupled to the outer member 111 andconfigured to control axial and/or rotational movement of the outermember 111. The handle 12 can include more or fewer than two actuators(e.g., one actuator, three actuators, four actuators, five actuators,six actuators, etc.).

According to several aspects of the technology, the treatment system 10optionally includes an introducer 103 for facilitating delivery of thetreatment device 101 into the vessel lumen. The introducer 103 cancomprise a proximal portion 103 a, a distal portion 103 b, a hub 105 atthe proximal portion 103, and an elongated sheath 110 extending distallyfrom the hub 105 to the distal portion 103 b of the introducer 103. Insome embodiments, the hub 105 is configured to be coupled to the suctionsource 18 and/or the fluid source 20 (e.g., via one or more ports). Thehub 105 and sheath 110 can be configured to receive a portion of thetreatment device 101 therethrough. For example, the treatment assembly100, the elongated member 102, and/or the sleeve 112 can be configuredto be inserted through the hub 105 and slidably positioned within alumen of the sheath 110. In some embodiments, the hub 105 comprises ahemostatic valve. According to several embodiments, the introducer 103includes a funnel at the distal end portion of the sheath 110. Severalexamples of such embodiments are depicted at FIGS. 12A-12C, 28A-28B,etc. The funnel can be configured to expand into apposition with thevessel wall proximate the distal end portion of the sheath 110, therebypreventing released obstructive material from traveling proximally ofthe introducer 103. In some embodiments, the system 10 does not includean introducer 103.

The treatment system 10 can optionally include a suction or aspirationsource 18 (e.g., a syringe, a pump, etc.) configured to be fluidlycoupled to a proximal portion of one or more of the introducer 103, thesleeve 112, and/or the elongated member 102 (and/or one or moresubcomponents thereof) to apply negative pressure therethrough. In someembodiments, the treatment system 10 includes a fluid source 20 (e.g., afluid reservoir, a syringe, pump, etc.) configured to be fluidly coupledto a proximal portion of one or more of the introducer 103, the sleeve112, and/or the elongated member 102 (and/or one or more subcomponentsthereof) to supply fluid to the treatment site. The fluid, for example,can be saline, contrast agents, a drug such as a thrombolytic agent,etc.

Actuators on the handle 12 or separate actuators connected directly tothe suction source 18 and/or the fluid source 20 may control theapplication of aspiration and/or flushing through the system 10 to thetreatment site. In some embodiments, a single actuator controls bothaspiration and flushing.

In some methods of use, the system 10 can be introduced into the venoussystem from a proximal site (e.g., the common femoral vein or femoralvein) and advanced in a retrograde direction (against normal blood flow)to a treatment site in a vein of the patient's leg. The system 10 canalso be introduced into the venous system from a distal site (e.g., apopliteal or more distal vein) and advanced in an antegrade direction(same direction as blood flow) towards the target treatment site. Insome embodiments, the system 10 is introduced into an artery.

FIGS. 3A and 3B are top views of a distal portion 101 b of a treatmentdevice 101 with a treatment assembly 100 in various states ofdeployment, accordance with embodiments of the present technology. Asshown in FIGS. 3A and 3B, the treatment assembly 100 can comprise acapture portion 200 and a cutting portion 300. The capture portion 200and the cutting portion 300 can be independently deployable. Forexample, the capture portion 200 is shown in a deployed (e.g., expanded)state in FIGS. 3A and 3B, and the cutting portion 300 is shown in acollapsed state in FIG. 3A and a deployed state in FIG. 3B.

The cutting portion 300 can comprise one or more cutting elements 302configured to cut through obstructive material in the vessel lumen asthe treatment assembly 100 is moved axially along the lumen, therebyseparating and/or releasing obstructive material from the vessel walland/or other obstructive material. FIG. 4 schematically depicts thedevice positioned within a blood vessel. The arms 304 of the cuttingportion 300 may be canted towards each other (rather than extending 180degree apart) when expanded so that the arms 304 and attached blades 302are at an angle θ that better approximates the curvature of the vesselwall. This geometry facilitates cutting obstructive material (such aschronic thrombus material) away from the curved vessel wall. In someembodiments, the angle between the two arms is less than 180 degrees. Insome embodiments, the angle is between 135 and 180 degrees.

The capture portion 200 can comprise one or more expandable meshstructures configured to engage, trap, or otherwise become enmeshed withobstructive material at the treatment site. In some embodiments, forexample as shown in FIGS. 3A and 3B, the cutting portion 300 can bepositioned proximally of some or all of the capture portion 200 alongthe longitudinal axis of the assembly 100 and/or device 101 such thatthe portion(s) of the obstruction separated from the vessel wall by theaxial movement of the cutting portion 300 are subsequently trapped inand/or become enmeshed with the capture portion 200 for removal from thepatient's body. For example, in some embodiments, all or a portion ofthe cutting portion 300 is positioned distally of the obstructivematerial and move proximally, and in some embodiments all or a portionof the cutting portion 300 is positioned proximally of the obstructivematerial and is moves distally towards the capture portion 200.

As depicted in FIGS. 3A and 3B, in some embodiments the capture portion200 and the cutting portion 300 comprise separately-formed components,both carried by the distal region of the elongated member 102. In suchembodiments, the capture portion 200 and the cutting portion 300 can beconfigured to collapse and expand independently of one another or viathe same actuation mechanism. For example, the capture portion 200 canbe a resilient structure configured to self-expand upon withdrawal of asleeve 112, while expansion of the cutting portion 300 may require anadditional actuation step by the operator (as detailed herein).Likewise, the cutting portion 300 can be a resilient structureconfigured to self-expand upon withdrawal of the sleeve 112, whileexpansion of the capture portion 200 may require an additional actuationstep by the operator (as detailed herein). According to some examples,both the capture portion 200 and cutting portion 300 are resilient,self-expanding structures.

In some embodiments of the present technology, for example as shown inFIGS. 3A and 3B, the elongated member 102 can comprise an outer member111 and an inner member 108 positioned through a lumen of the outermember 111. A proximal end of each of the outer member 111 and the innermember 108 can be disposed at the handle so that the inner and outermembers 108, 111 can be manipulated by an operator. In some embodiments,a distal end portion 200 b of the capture portion 200 is coupled to thedistal region of the inner member 108. In the embodiment shown in FIGS.3A and 3B, for example, only the distal end portion 200 b of the captureportion 200 is coupled to the distal region of the inner member 108 andthe proximal end portion 200 a is free to expand radially away from theinner member 108 when the sleeve 112 is withdrawn. As a result, when thecapture portion 200 is in the expanded state, the proximal end portion200 a defines a proximal opening 206 through which obstructive materialseparated by the cutting portion 300 can pass to trap the obstructivematerial within an inner cavity defined by the capture portion 200. Insome embodiments, only the proximal end portion 200 a of the captureportion 200 is coupled to the inner member 108 and the distal endportion 200 b is free and defines a distal opening in the expandedstate. In some embodiments, both the proximal end portion 200 a and thedistal end portion 200 b are coupled to the inner member 108.

Referring still to FIGS. 3A and 3B, a distal end portion 300 b of thecutting portion 300 can be coupled to the inner member 108, and aproximal end portion 300 a of the cutting portion 300 can be coupled toa distal end portion of the outer member 111. The distal end portion 300b of the cutting portion 300 can be coupled to the inner member 108 at alocation that is distal to, generally aligned with, or proximal to theproximal terminus of the capture portion 200. In some embodiments, thedistal end portion 300 b is slidable along the inner member 108. In suchembodiments, the inner member 108 may optionally include a distal and/orproximal stop to limit distal and/or proximal axial movement,respectively, of the cutting portion 300 along the inner member 108. Inany case, movement of the outer member 111 relative to the inner member108 can cause the cutting portion 300 to radially expand and collapse.For example, axial movement of the outer member 111 relative to theinner member 108 in a distal direction can cause the cutting portion 300to radially expand, while axial movement of the outer member 111relative to the inner member 108 in a proximal direction can cause thecutting portion 300 to radially collapse.

According to several embodiments of the present technology, the cuttingportion 300 may comprise a tube with one or more regions removed alongthe distal portion to form expandable arms 304 (labeled individually as304 a and 304 b). In some embodiments, the outer member 111 and the tubeforming the cutting portion 300 are different portions of the samecontinuous tube. As previously described, distal movement of the outermember 111 with respect to the inner member 108 causes the arms 304 tobuckle and/or bend outwardly away from the longitudinal axis of theelongated member 102, as shown in FIG. 3B.

The arms 304 can include one or more segments 306 a, 306 b, 308 a, and308 b (referred to collectively as “segments 309”) and one or morejoints 310. The joints 310 can be positioned along the arms 304 betweensegments 309 and/or between a respective arm 304 and the rest of thetube from which the arms 304 are cut (e.g., the proximal and distal endportions of the arms 304). The joints 310 can be portions of the arms304 that are configured to preferentially flex or bend relative to thesegments 309 and/or the proximal and distal end portions of the tube. Insome embodiments, one or more of the joints 310 can be formed byopposing recesses at a desired location along the arm 304 (e.g., aliving hinge), and in other embodiments one or more of the joints 310can be one or more small pins, elastic polymeric elements, mechanicalhinges and/or other devices that enable one segment to pivot or bendrelative to another.

In the embodiment shown in FIGS. 3A and 3B, each of the arms 304includes a distal joint at its distal end portion, a proximal joint atits proximal end portion, and an intermediate joint positioned along thelength of the respective arm 304 between the distal and proximal joints.In response to longitudinal stresses caused by relative axial movementof the inner and outer members 108, 110, the arms 304 deform into apredetermined shape biased by the configuration and/or relativepositions of the joints 310. For example, in the illustrated embodiment,each of the arms 304, when deployed, includes a generally linear distalsegment 306 a, 306 b and a generally linear proximal segment 308 a, 308b. In some embodiments, each of the arms 304, when deployed, includes agenerally curved distal segment 306 a, 306 b and/or a generally curvedproximal segment 308 a, 308 b.

The cutting portion 300 can include one or more cutting elements, suchas blades 302, fixedly coupled to one or more segments of the arms. Inthe embodiment shown in FIGS. 3A and 3B, each of the blades 302 has asharpened edge that faces proximally when the cutting portion 300 is inthe deployed and/or expanded state. The blades 302 may comprise a firstmaterial while the arms 304 and/or cutting portion 300 may comprise asecond material different than the first material. For example, theblades 302 may comprise stainless steel while the arms 304 and/orcutting portion 300 may comprise a resilient and/or superelastic metalalloy, such as Nitinol, a cobalt-chromium alloy, and others. In someembodiments, the blades 302 comprise the same material as the arms 304.According to several embodiments, the cutting elements are notseparately-formed structures and instead are formed of a sharpenedsurface of the cutting portion 300.

FIG. 5 is a side view of a distal portion 10 b of a treatment system 10configured in accordance with several embodiments of the presenttechnology, with the treatment assembly 100 shown in an expanded state.The assembly 100 can comprise an elongated member 102 and a cuttingportion 300 that are generally similar to the elongated member 102 andcutting portion 300 discussed above with reference to FIGS. 3A and 3B.The capture portion 200 shown in FIG. 5 can be generally similar to thecapture portion 200 shown in FIGS. 3A and 3B, except the capture portion200 shown in FIG. 5 includes a flexible braided distal region 202 and amore rigid proximal region 204 formed of a laser-cut tube or sheet ofmaterial. The tube forming the proximal region 204 can be continuouswith or separate from a distal region of the cutting portion 300. Theproximal region 204 can have a greater chronic outward force and/orradial resistive force as compared to the distal region 202, which canbe beneficial for maintaining the patency of the proximal opening 206once the assembly 101 and/or device 101 is deployed. In someembodiments, the cutting portion 300 may be fixed to or integral to thecapture portion 200. For example, the proximal, open end region 204 ofthe capture portion 200 may be constructed from a cut nitinol tube. Themain structure of the cutting portion 300 may also be constructed from acut nitinol tube, as described above. The nitinol tube of region 204 andof cutting portion 300 may be the same nitinol tube with two sections ofcut pattern. Alternately, nitinol tube of region 204 and of cuttingportion 300 may be two separate tubes which are mechanically coupled,glued, soldered or welded, to fixedly couple the capture portion 200with the cutting portion 300.

FIGS. 6 and 7 shows a distal portion of a device 101 configured inaccordance with several embodiments of the present technology. As shownin FIGS. 6 and 7, in some embodiments the cutting portion 300 and thecapture portion 200 are separate components that are spaced apart andslidably coupled. In this embodiment, the blades of the cutting portion300 of assembly 100 and/or device 101 can face proximally or facedistally, depending on how the capture portion 200 and cutting portion300 are configured to be used with respect to each other. In onevariation, shown in FIG. 6, the cutter is oriented in the distaldirection. According to some methods of use, the treatment assembly 100is initially positioned in the blood vessel lumen such that both thecapture portion 200 and cutting portion 300 are distal to theobstructive material. The two portions 200, 300 can be expanded, forexample, by retraction of a sheath, or by any of the expansionmechanisms described herein. The cutting portion 300 can be pulledproximally to cut through the obstructive material, and subsequently thecapture portion 200 can be pulled proximally cut gather the cutobstructive material. In some embodiments, the cutting portion 300 andcapture portion 200 can alternately and/or simultaneously be pulled backto cut and capture the obstructive material.

In another variation, as shown in FIG. 7, the blades 302 on the cuttingportion face distally. According to some methods of use, the treatmentassembly 100 is initially positioned in the blood vessel lumen such thatthe capture portion 200 is distal to the obstructive material and thecutting portion 300 is proximal to the obstructive material In use, thecutting portion 300 can be moved axially towards the capture portion 200to separate obstructive material from the wall and push the obstructivematerial into the capture portion 200.

In some embodiments, the cutting portion 300 of the assembly 100 may bean expandable tubular structure with integrated cutting elements. FIG.8, for example, shows an assembly 100 with a cutting portion 300comprising a substantially tubular, stent-like portion 502 and aplurality of arms 504 extending away from the stent-like portion 502 ina distal direction. The cutting portion 300 can further include aplurality of cutting elements 302, each disposed at an end portion of acorresponding arm 502. For example, in some embodiments, the cuttingportion 300 is constructed from a cut nitinol tube with integratedcutting elements 302 (such as blades) arranged in a circular array. Thearms 504 and cutting elements 302 may be spaced apart about acircumference of the cutting portion 300 such that the cutting portion300 is configured to create a cut that extends circumferentially aroundthe blood vessel wall. Such a feature may be advantageous in somesituations due to the amount of obstructive material in the vesseland/or the difficulty with separating the obstructive material from thevessel wall. The cutting edge of the cutting elements 302 may besharpened and configured to mechanically cut and/or otherwise modify theobstructive material. Additionally or alternatively, the cutting edge ofthe cutting elements may be configured to chemically cut and/orotherwise modify the obstructive material.

In some embodiments, one, some, or all of the arms 504 are tapered. Insome embodiments the arms 504 are not tapered and/or have a generallyconstant width and/or arc length along their lengths. In a collapsedstate (not shown), the distal end portions can be circumferentiallyspaced apart while the intermediate portions of the projectionscircumferentially overlap with the circumferentially adjacentprojections. In an expanded state (FIG. 8), the end portions of the arms504 can be circumferentially spaced apart by a greater arc length thanwhen the device was in the collapsed state, and the intermediateportions circumferentially overlap to a lesser extent than in thecollapsed state or do not overlap at all.

As shown in FIG. 8, the arms 504 and/or cutting elements 302 can bedirected distally towards the capture portion 200. In several of suchembodiments, the cutting portion 300 can be configured to move axiallyrelative to the capture portion 200. For example, the cutting portion300 can be slidably coupled to an outer elongated member 111 while thecapture portion 200 can be coupled to an inner elongated member 108.Other configurations that allow independent movement of the captureportion 200 and the cutting portion 300 are possible. In use, thecutting portion 300 can be deployed and/or otherwise positionedproximally of the obstructive material with all or a portion of thecapture portion 200 positioned distally of the obstructive material. Thecutting portion 300 can be pushed distally to cut the obstructivematerial and separate the obstructive material from the vessel walland/or from other obstructive material.

FIG. 9A shows a treatment assembly 100 that is generally similar to thetreatment assembly 100 of FIG. 8, except in FIG. 9A the plurality ofarms 504 extend away from the stent-like portion 502 in a proximaldirection. In use, the capture portion 200 and cutting portion 300 canbe deployed and/or otherwise positioned distally of the obstructivematerial and pulled proximally to cut the obstructive material. FIG. 9Bdepicts the treatment assembly 100 in a collapsed state within a sleeve112 (shown in cross-section).

In some embodiments where the capture portion 200 and cutting portion300 are separately-formed components, the capture portion 200 and thecutting portion 300 can be fixed to one another such that axial and/orrotational movement of one of the portions 200, 300 causes axialmovement of all or a portion of the other portion 200, 300. For example,a distal end portion 300 b of the cutting portion 300 can be fixedlycoupled to a proximal end region 200 a of the capture portion 200. Ifboth the cutting portion 300 and the capture portion 200 are fairlyrigid structures with high column strength (such as a laser-cut tube orsheet of material), axial movement of the cutting portion 300 will causeaxial movement of the entire capture portion 200 and vice versa. If oneof the capture portion 200 or the cutting portion 300 is a more flexiblestructure with low column strength (such as a braid) while the other isa more rigid structure, axial movement of the more rigid structure maycause an end region of the more flexible structure to collapse axially,while axial movement of the flexible structure may not cause any axialmovement of the more rigid structure.

According to several embodiments, the capture portion 200 and thecutting portion 300 can be rotated and/or moved axially independently ofone another. For example, the elongated member 102 can comprise a firstelongated member coupled to the capture portion 200 and a secondelongated member coupled to the cutting portion 300. The first andsecond elongated members can be configured to move axially relative toone another and/or rotate relative to one another (for example, whereone elongated member is received within a lumen of the elongatedmember), thereby causing axial movement and/or rotation of thecorresponding attached capture and cutting portions 200, 300. In someembodiments, the capture portion 200 and the cutting portion 300 can bemounted to the same elongated member, but one of the capture portion 200or the cutting portion 300 is fixed axially and/or rotationally to theelongated member while the other is free to slide along and/or rotateabout the elongated member. In some embodiments the capture portion 200and cutting portion 300 are both fixed axially and/or rotationally tothe elongated member.

In any of the embodiments in which the capture portion 200 and thecutting portion 300 are separately-formed components, the captureportion 200 and the cutting portion 300 may be configured to radiallyexpand and collapse independently of one another or via the sameactuation mechanism, as discussed herein.

In some embodiments of the present technology, the cutting portion 300is integrated within the structure of the capture portion 200 or viceversa. For example, as shown in FIG. 10, the capture portion 200 canhave one or more cutting elements facing proximally along a proximalsurface of the capture portion and configured to cut obstructivematerial when the device is pulled back. The cutting elements may beangled with respect to the longitudinal axis of the elongated member 102to optimize the ability of the blades to slide through the toughmaterial as the device is pulled proximally. The cutting elements can beone or more separately-formed blades coupled to the proximal surface ofthe capture portion 200. For example, the cutting elements can beseparately-formed blades 302 that are mechanically attached to thecapture portion 200 (for example via the latching configurationdescribed with respect to FIGS. 19A and 19B). In such embodiments, thestruts defining the proximal opening 206 of the capture portion 200 canhave slots or other features to mechanically lock the blades 302 inplace relative to the struts. Additionally or alternatively, the cuttingelements can be formed of the same material and/or structure as thecapture portion 200. For example, the cutting elements can be formed ofa sharpened, proximally facing surface of the capture portion 200.

In some embodiments, for example as shown in FIG. 11, the cuttingelements and/or projections carrying the cutting elements areconstructed from the same metal tube that comprises the proximal portion204 of capture portion 200 and include protruding tapered elements thatfurl together when collapsed, similar to FIGS. 8-9B. While the assembly100 in FIG. 11 shows a capture portion 200 comprising a braid, in someembodiments the capture portion 200 may comprise a laser-cut stent.

Regarding FIGS. 8, 9A, 9B, 11, 27A, 27B, 28A, and 28B, one, some, or allof the projections (such as arms 504, arms 652, projections 1502, etc.)can include a cutting element 302. The cutting element can be coupled tothe projection (such as a blade) or the cutting element can be cut intothe tube forming the treatment assembly 100. In some embodiments, thecutting elements are positioned at the distal end portions of theprojections. In these and other embodiments, the cutting elements may bepositioned along all or a portion of one or both side surfaces of agiven projection.

When the treatment assembly 100 is in a collapsed state, the projectionscan be compressed together, and when the treatment assembly 100 is in anexpanded state the projections can expand outward to contact and/orconform to the vessel wall. When the treatment assembly is pulled intoand through the obstructive material, the cutting elements cut theobstructive material away from the vessel wall. The cutting elements maybe configured to be angled such that pulling the device causes thecutting surface to slice across the obstructive material to improve thecutting action. The distal and/or side edges of one, some, or all of theprojections 312 and/or blades can be generally linear, generally curved,serrated, and other have suitable configurations.

The devices and systems of the present technology can optionally includea sheath 110 with a self-expanding funnel configured to extend distallyfrom the distal opening of the sheath 110. Such a feature can bebeneficial for corralling the captured obstructive material into thesheath 110 as the treatment assembly 100 is withdrawn into the sheath110. An example system 10 including a funnel 700 is shown in FIGS. 12Aand 12B. As shown in FIG. 12A, the treatment device 101 with treatmentassembly 100 can be delivered in a collapsed state through a sheath 110with the funnel 700 in an expanded state. Once positioned, the sleeve112 can be retracted to cause the treatment assembly to expand. FIG. 12Bshows the sleeve 112 partially retracted to show the capture portion 200of the treatment assembly expanded 100. FIG. 12C shows the sleeve 112fully retracted to show the cutting portion 300 of the treatmentassembly 100 expanded. Additionally or alternatively, aspiration may beapplied to the sheath 110 with or without a funnel to further reduce therisk of embolization. The funnel 700 can be used with any of the systemsdetailed herein.

A. Example Capture Portions

Several capture portion configurations are shown and described withrespect to FIGS. 13-16. The cutting portions 300 are not shown in FIGS.13-16 for ease of viewing the capture portions 200. It will beappreciated that the present disclosure is not limited to the captureportions 200 depicted in the drawings.

FIG. 13 shows a capture portion comprising a braided or woven captureportion 200 having a closed distal end portion and an opening at itsproximal end portion. The braid has a tapered shape with across-sectional dimension that decreases in a distal direction. Thedistal end of the braid may be cinched together with a tip component245, that constrains the ends of the braid wires together. The tipcomponent 245 may have a tapered or rounded distal edge to reduce thetrauma to vessel wall as the assembly 100 and/or device 101 is deliveredto the treatment site, and to facilitate crossing the device throughchronic thrombus site. The tip component 254 may also affix theactuation member 102 to the distal end of the capture device.

FIG. 14 shows a capture portion 200 comprising a laser-cut meshstructure having a closed distal end portion and an opening at itsproximal end portion. The mesh structure has a tapered shape with across-sectional dimension that decreases in a distal direction. Theclosed distal portion may be cinched closed with a tip component 245that constrains the ends of the cut tube pattern together. As above, thetip component 245 may have a tapered or rounded distal end and also maybe used to affix the elongated member 102 to the closed end of portionmember 200.

FIG. 15 shows a capture portion 200 comprising a flexible, tapereddistal region 202 coupled to a more rigid proximal region 204. Thedistal region can comprise a braid, and the proximal region 204 cancomprise a laser-cut tube or sheet of material. The proximal region 204can have a greater chronic outward force and/or radial resistive forceas compared to the distal region 202, which can be beneficial formaintaining the patency of the proximal opening 206 once the assembly100 is deployed in the vessel lumen.

In any of the embodiments disclosed herein, the capture portion 200 caninclude an open cell framework or body. According to severalembodiments, the entrance to the capture portion 200 is slanted tofacilitate capture of the obstructive material into the capture portion200. In some embodiments, a distal portion 200 b of the capture portion200 is generally tubular (e.g., cylindrical), and the proximal endportion 200 a of the capture portion 200 tapers proximally down to theelongated member 102 (or component thereof). Likewise, the proximal endportion 200 a of the capture portion 200 can be generally tubular (e.g.,cylindrical), and the distal portion 200 b of the capture portion 200tapers distally down to the elongated member 102 (or component thereof).

In some embodiments, the capture portion 200 can have an open proximalend and a closed distal end. In some embodiments, the capture portion200 has an open proximal end and an open distal end. In someembodiments, the capture portion has a closed proximal end and an opendistal end.

In some embodiments, the capture portion 200 comprises a singleexpandable mesh structure. In some embodiments, for example as depictedin FIG. 16, the capture portion 200 comprises a plurality of expandablestructures 200 a, 200 b. The different structures can have the same ordifferent shapes, can expand to the same or different maximumcross-sectional dimensions, and/or can comprise the same or differenttype of mesh structure (e.g., a braid, a laser-cut tube, a laser-cutsheet, a weave, etc.).

In some embodiments, the capture portion 200 comprises a mesh structureformed of an elastic or spring material (e.g. stainless steel or cobaltchromium alloy), superelastic material (e.g., Nitinol.) or otherresilient or self-expanding material configured to self-expand whenreleased from the restraining sleeve 112. For example, in someembodiments the mesh is a self-expanding stent and/or stentriever.According to several embodiments, the mesh structure is a laser-cut tubeor sheet of material. The material, for example, can comprise aresilient, elastic, and/or superelastic metal alloy or polymer. In someembodiments, the mesh structure comprises a plurality of braided wires(e.g., filaments, threads, sutures, fibers or the like) that have beeninterwoven to form a structure having openings. The mesh and/or braidcan be composed of metals, polymers, composites, and/or biologicmaterials. Polymer materials can include Dacron, polyester,polypropylene, nylon, Teflon, polytetrafluoroethylene (PTFE),tetrafluoroethylene, polyethylene terephthalate, polylactic acid (PLA)silicone, polyurethane, polyethylene, polycarbonate, styrene, polyimide,PEBAX, Hytrel, polyvinyl chloride, high-density polyethylene,low-density polyethylene, polyether ether ketone (PEEK), rubber, latex,and/or other suitable polymers known in the art. Other materials knownin the art of elastic implants can also be used. Metal materials caninclude, but are not limited to, nickel-titanium alloys (e.g. Nitinol),platinum, cobalt-chromium alloys, stainless steel, tungsten or titanium,or alloys of any of these metals. In certain embodiments, metalfilaments may be highly polished and/or surface treated to furtherimprove their hemocompatibility. The capture portion 200 can beconstructed solely from metallic materials without the inclusion of anypolymer materials, solely from polymer materials without the inclusionof any metallic materials, or a combination of polymer and metallicmaterials.

In some embodiments, some or all of the wires of the capture portion 200are drawn-filled tube (“DFT”) wires having a radiopaque core (e.g.,platinum, tantalum, gold, tungsten, etc.) surrounded by an elastic orsuperelastic material (e.g., Nitinol, a cobalt-chromium alloy, etc.).The radiopaque core may comprise about 5% to about 50% (e.g., 10%, 15%,20%, 25%, 30%, 35%, 40%, 45%) of the total-cross-sectional area of theindividual wires. Moreover, some or all of the wires may have a wirediameter of about 0.003 inches to about 0.015 inches (e.g., 0.008inches, 0.009 inches, 0.01 inches, etc.). In some embodiments, all ofthe wires have the same diameter, and in other embodiments some of thewires have different diameters.

B. Example Cutting Portions

According to several embodiments of the present technology, the cuttingportion 300 may comprise separate cutting element, such as blades,attached to an expandable structure forming the cutting portion 300. Asdescribed previously, the cutting portion may face distally orproximally as shown in FIGS. 6 and 7, and also in FIGS. 8 and 9A,respectively. The cutting portion may also be and may be fixed tocapture portion as shown in FIGS. 10 and 11. The expandable structurecan be configured to angle the cutting elements such that, when thedevice is pulled towards and then through the obstructive material, thecutting elements cut the obstructive material away from the vessel wall.Continued withdrawal of the device then pulls the obstructive materialinto the capture portion 200. An example of a such an expandablestructure is shown in FIG. 17A. Similar to the cutting portion 300described with respect to FIGS. 3A and 3B, the cutting portion 300 inFIG. 17A can be formed of a tube having two or morelongitudinally-extending slots that create at least two arms 304configured to bend radially outwardly when the tube is shortened. Thelongitudinal slots can be formed such that the arms 304 have joints 310that bend when the arms 304 are expanded.

As shown in FIG. 17B, the arms 304 of the cutting portion 300 may becanted towards each other (rather than extending 180 degree apart) whenexpanded so that the arms 304 and attached blades 302 are at an angle θthat better approximates the curvature of the vessel wall. This geometryfacilitates cutting obstructive material (such as chronic thrombusmaterial) away from the curved vessel wall. In some embodiments, theangle between the two arms is less than 180 degrees. In someembodiments, the angle is between 135 and 180 degrees.

As shown in FIG. 18A, in some embodiments the cutting portion 300 caninclude a positioning arm 314 disposed circumferentially between the twoarms 304 having cutting elements. As depicted in FIG. 18B, when thecutting portion 300 is in an expanded state, the positioning arm 314pushes against a portion of the vessel wall opposite the elongatedmember 102 and improves the position of the cutting elements for cuttingand/or separating the obstructive material from the vessel wall.

FIGS. 19A and 19B are exploded and assembled views, respectively, of anexample blade attachment assembly configured in accordance with severalembodiments of the present technology. The assembly includes a portionof an arm 304 (or other portion of the cutting portion 300 and/orcapture portion 200), a blade 302, and a coupler 1400. Any portion ofthe cutting portions 300 and capture portions 200 described herein caninclude one or more openings, such as openings 324 shown extendingthrough arm 304. The openings 324 can be configured to receive acorresponding tab 320 extending from the blade 302 in a direction awayfrom the sharpened edge of the blade 302. The tabs 320 can have one ormore openings 322 configured to receive a corresponding protrusion 1302positioned along the coupler 1400. The tabs 320 on the blades 302 arepositioned through the openings 324 on the arm 304 such that theopenings 322 on the tabs 320 are exposed on the non-receiving side ofthe arm openings 324. The protrusions 1302 a, 1302 b, and 1302 c on thecoupler 1400 are then positioned through the tab openings 322, therebylocking the blade 302 onto the arm 304. The protrusions 1302 may alsoinclude features which allow the width of the protrusion to be increasedand locked after insertion through slots 324, to further secure coupler1400 and blade 302 to arm 304, as illustrated in the end protrusions1302 a and 1302 b.

In some embodiments, as shown in FIGS. 20A and 20B, the treatmentassembly 100 includes an elongated shaft 102 comprising first and secondelongated members 111, 108 and a cutting portion 300 comprising acutting element 2010 that extends helically and/or spirally around thelongitudinal axis of the elongated shaft 102. The second elongatedmember 108 can be configured to be positioned within a lumen of thefirst elongated member 111 and extends distally beyond a distal terminusof the first elongated member 111. In some embodiments the axialpositions of the first and second elongated members 111, 108 are fixed,and in some embodiments the first and second elongated members 111, 108are slidably disposed relative to one another. In any case, the firstand second elongated members 111, 108 may be configured to rotaterelative to one another. The treatment assembly 100 may optionallyinclude a tapered distal tip 2020 at the distal end portion 108 b of thesecond elongated member 108.

The cutting element 2010 can have a proximal end portion 2010 a at adistal end portion 111 b of the first elongated member 111, a distal endportion 2010 b at a distal end portion 108 b of the second elongatedmember 108, and an intermediate portion 2010 c extending between theproximal and distal end portions 2010 a, 2010 b. The intermediateportion 2010 c wraps around the longitudinal axis of the treatmentassembly 100. The cutting element 2010 is transformable between acollapsed configuration (FIG. 20A) and an expanded configuration (FIG.20B). In the collapsed configuration, the cutting element 2010 is woundaround the second elongated member 108 and has an outer diameterslightly larger than that of the second elongated member 108. Thecutting element 2010 may wrap around the longitudinal axis less than oneturn (360 degrees) or more than one turn (including multiple turns).When the second elongated member 108 is rotated with respect to thefirst elongated member 111 (or vice versa) in a first direction, thecutting element 2010 unwinds and expands radially outwardly, as shown inFIG. 20B. Rotation of the second elongated member 108 with respect tothe first elongated member 111 (or vice versa) in a second directionopposite the first direction forces the cutting element 2010 to winddown onto the second elongated member 108, thereby radially collapsingthe cutting element 2010. The amount of rotation controls the amount ofexpansion, with the actual expansion percentage depending on, forexample, the initial diameter of the elongated shaft 102 and the lengthof the cutting element 2010.

In some embodiments, the cutting element 2010 comprises a ribbon havinga width w (labeled in FIG. 20A) and longitudinal sides 2012 a, 2012 b(referred to collectively as “longitudinal sides 2012”). The width canbe constant along the length of the ribbon or may vary. One of thelongitudinal sides 2012 can be proximally facing 2012 a and one of thelongitudinal sides can be distally facing 2012 b. The ribbon can be madefrom, for example, one or more resilient and/or superelastic metals orpolymers. One or both longitudinal sides 2012 of the ribbon may beconfigured to cut obstructive material in a vessel lumen. For example,in some embodiments one or both longitudinal sides 2012 of the ribbonare sharpened. Additionally or alternatively, one or both longitudinalsides 2012 of the ribbon may be serrated. One or both longitudinal sides2010 may have both serrated and sharpened portions to enhance thecutting ability of the cutting element 2010 when moved (e.g., rotatedand/or translated) through obstructive material. In some cases it may bebeneficial to have the proximally facing longitudinal side 2012 asharpened and/or serrated and the distally facing longitudinal side 2012b atraumatic and/or rounded. This configuration enables the device tocut through obstructive material when pulled and/or rotated in aproximal direction while reducing the risk of trauma to the vessel wallduring advancement of the treatment assembly 100 to a treatment site.According to several embodiments, only the portion of the proximallyfacing longitudinal side 2012 a that is proximal of the maximum diameterof the cutting element 2010 (when the cutting element 2010 is in anexpanded state) is configured to cut through obstructive material. Thisconfiguration can reduce trauma to the native vessel wall as thetreatment assembly 100 is pulled proximally and/or rotated through atreatment site.

Once the cutting element 2010 is expanded, the treatment assembly 100can be rotated, translated, or both in order to cut obstructivematerial. In some embodiments, expansion of the cutting element 2010 cancut obstructive material. The cutting element 2010 can be repeatedlyexpanded and collapsed to engage and cut obstructive material. Movementof the cutting element 2010 to cut obstructive material may be performedmanually by the user, facilitated by actuators on handle 12, orperformed automatically with motors on handle 12.

While only a single cutting element 2010 is shown in FIGS. 20A and 20B,the present technology includes treatment assemblies comprising morethan one wrapped cutting element (e.g., two wrapped cutting elements,three wrapped cutting elements, four wrapped cutting elements, etc.). Asbut one example, FIGS. 21A and 21B show a treatment assembly 100 havingfirst and second cutting elements 2010 and 2014. The treatment assembly100 is shown in a collapsed state in FIG. 21A and an expanded state inFIG. 21B. Each of the cutting elements 2010, 2014 has a proximal endportion 2010 a, 2014 a, respectively (2010 a not visible in FIGS. 21Aand 21B), disposed at the distal end portion 111 b of the firstelongated member 111, and a distal end portion 2010 b, 2014 b,respectively, disposed at the distal end portion 108 b of the secondelongated member 108. The proximal end portions 2010 a, 2014 a can becoupled to the first elongated member 111 at different circumferentiallocations that are spaced apart about the circumference of the firstelongated member 111. Whether two or more than two cutting elements areutilized, the spacing may be the same between adjacent cutting elements2010 or may be different. In some embodiments, the proximal end portions2010 a, 2014 a are coupled to the first elongated member 111 atdiametrically opposed locations. In other embodiments, the proximal endportions 2010 a, 2014 a have other circumferential spacings. Likewise,the distal end portions 2010 b, 2014 b can be coupled to the secondelongated member 108 at different circumferential locations that arespaced apart about the circumference of the second elongated member 108.The spacing may be the same between adjacent cutting elements 2010 ormay be different. In some embodiments, the distal end portions 2010 b,2014 b are coupled to the second elongated member 108 at diametricallyopposed locations. In other embodiments, the distal end portions 2010 b,2014 b have other circumferential spacings. In those embodiments havingtwo or more cutting elements 2010, the different cutting elements 2010can have the same or different widths.

The diameter of the elongated shaft 102 (and/or one or more componentsthereof), the number of cutting elements 2010, the angle at which thecutting element 2010 couples to the elongated shaft 102 (and/or one ormore components thereof), the number of windings, and the width of thecutting element 2010 may be varied to create a desired expanded cuttingconfiguration. As used herein with respect to the wrapped cuttingelements, “length” is measured along the longitudinal axis of thecutting element 2010 which extends through a cross-section of thecutting element 2010. In some embodiments, the elongated shaft 102 is 3mm in diameter, the length of the cutting element 2010 is 22 mm, thewidth of the cutting element 2010 is 2 mm, and the cutting element 2010is coupled to the elongated shaft 102 at an angle of 60 degrees. In thecollapsed state, the cutting element 2010 can be tightly wound aroundthe elongated shaft 102 two times. In the expanded state (e.g., afterrotation of the second elongated member 108), the cutting element 2010is unwound until it makes only one turn around the elongated shaft 102,which approximately doubles the maximum diameter of the cutting element2010 (in this case, to about 6 mm). According to some embodiments, thecutting element 2010 is coupled to the elongated shaft 102 at an angleof 60 degrees, is 33 mm long and wound around the elongated shaft 102approximately three times. In the expanded state, the cutting element2010 is unwound until it makes one turn around the elongated shaft 102,which approximately triples the maximum diameter of the cutting element2010 (in this case, about 9 mm). In some embodiments, the cuttingelement 2010 has a length of 40 mm, is coupled to the elongated shaft102 at an angle of 45 degrees, and is wound around the elongated shaft102 approximately three times. In certain embodiments, the cuttingelement 2010 has a length of 57 mm, is coupled to the elongated shaft102 at an angle of 30 degrees, and is wound around the elongated shaft102 approximately 3 times. In the latter two examples, the cuttingelement 2010 can be unwound to its fully expanded diameter in which ithas one turn and a diameter that is about 3 times its starting diameter(e.g., around 9 mm). However, because the attachment angle is less acute(as compared to the earlier examples), but over a longer length due tothe less acute attachment angle. For example, at the 60 degreeattachment angle, the helix length is about 16 mm, for the 45 degreeattachment angle, the helix length is about 28 mm, and for the 30 degreeattachment length the helix length is 49 mm, all over 3 windings.

The fully expanded diameter of the cutting element 2010 also depends onthe design of the attachment of the proximal and distal end portions2010 a, 2010 b of the cutting element 2010 to the first and secondelongated members 111, 108, respectively, of the elongated shaft 102.For example, if an end of the cutting element 2010 were fixedly weldedor soldered to the corresponding first or second elongated member 111,108, the cutting element 2010 would remain tangent or near tangent tothe elongated shaft 102 as it was unwound, creating one slope angle ofhelical taper on each end of the cutting element 2010. Whereas, if thecutting element 2010 were allowed to angle away from the elongated shaft102 to a certain degree or was freely allowed to hinge at the elongatedshaft 102, the helical taper would be another slope angle. Each type ofhelical taper would alter the fully unwound diameter to some extent.

In some embodiments, the width of the cutting element 2010 can beselected based on a desired gap length g (see FIG. 20A) between windingswhen the cutting element 2010 is fully wound (e.g., in a collapsedstate). Additionally or alternatively, the width w (see FIG. 20A) of thecutting element 2010 can depend on how many cutting elements 2010 thereare in the treatment assembly 100. If the treatment assembly 100 hasmore than one, the width of the individual cutting elements 2010 will beless than if only a single cutting element 2010 were used. The greaterthe width w of a given cutting element 2010, the more resistance it willhave to bending distortion when under load, and the more effectively itcan cut obstructive material. As demonstrated, there are trade-offsbetween the number of cutting elements 2010 and performance of eachcutting element 2010.

As discussed, the second elongated member 108 may rotate with respect tothe first elongated member 111 when expanding the treatment assembly100, and in some embodiments the second elongated member 108 may alsotranslate with respect to the first elongated member 111 to axiallycompress or elongate the cutting element 2010. The ability of thecutting element 2010 to be axially compressed or elongated depends inpart on how the proximal and distal end portions 2010 a, 2010 b of thecutting element 2010 are coupled to the first and second elongatedmembers 111, 108 of the elongated shaft 102, and whether the attachmentenables the attachment angle to vary, as axial compression or elongationof the cutting element 2010 increases or decreases the angle ofattachment. The ability to axially compress and elongate the cuttingelement 2010 while in the expanded state improves the cutting efficiencyof the treatment assembly 100. For example, the treatment assembly 100may separate and capture obstructive material from a combination of oneor more expanded wrapped cutting elements rotating, translating,expanding, and/or compressing through obstructive material of atreatment site. Additionally, the cutting element 2010 may be partiallyunwound for a first cutting pass, and then further unwound to a moreexpanded and/or fully expanded state for a second cutting pass, and soforth for multiple cutting passes until the desired effect is achieved.

In some variations, the cutting element 2010 is integral to the firstelongated member 111. For example, the first elongated member 111 cancomprise a tubular member that has been cut in a helical and/or spiralpattern at its distal portion to create one or more helical strips. Assuch, the first elongated member 111 and the cutting element 2010 cancomprise the same material. The distal end portion 2010 b of the cuttingelement 2010/distal end portion 111 b of the first elongated member 111can be fixed to the distal end portion 108 b of the second elongatedmember 108. When the second elongated member 108 is rotated with respectto the first elongated member 111, the cut strip (now the cuttingelement 2010) is unwound and expands outward. The foregoing embodimentsadvantageously do not require any attachment design and therefore reducethe number of manufacturing processes.

In another variation, the cutting element 2010 is formed from onematerial that has the required mechanical properties including theability to be wound and unwound, sharpened, and hold sufficient rigidityto have an effective cutting action when manipulated as described above,and the first elongated member 111 is formed from a separate tube. Thefirst elongated member 111 is then attached to a second tube thatextends proximally from the treatment assembly 100 and that has suitableproperties for a catheter shaft component, for example cost,flexibility, etc.

There are many possible methods to attach the proximal end portion 2010a of the cutting element 2010 to the first elongated member 111 and thedistal end portion 2010 b to the second elongated member 108, forexample via soldering, welding, gluing, mechanical attachment, or somecombination thereof. As noted above, the method of attachment can affectthe specific expansion performance and strength of attachment of thecutting element 2010 when it is expanded and used to remove obstructivematerial.

In some embodiments, for example as shown in FIGS. 22A, 22B, and 22C,the distal end portion 2010 b of the cutting element 2010 ismechanically captured between the distal end portion of the secondelongated member 108 and a securing element 2220. The distal end portion2010 b of the cutting element 2010 can be coupled to a cylindricalcoupler 2210 (e.g., a dowel, a tube, or other cylindrical component) andextend from the coupler 2210 at an angle. The angle between the coupler2210 and the cutting element 2010 forms the angle at which the cuttingelement 2010 extends from the second elongated member 108. In someembodiments, the coupler 2210 is integral with the cutting element 2010.For example, the coupler 2210 can be constructed by rolling the cuttingelement 2010 into a tight cylinder at the distal end portion 2010 b. Insome embodiments, the coupler 2210 is a separate component that isattached to the distal end portion 2010 b of the cutting element 2010.In any case, the coupler 2210 can be configured to be received within agroove 2230 extending along a distal portion of the second elongatedmember 108. The securing element 2220 can be a band that is configuredto be slidably disposed over the outer surface of the second elongatedmember 108. The securing element 2220 can have a slot 2225 extendingalong less than its entire length. The slot 2225 can be continuous withan opening at a distal end of the securing element 2220.

As shown in FIG. 22B, the cutting element 2010 can be mechanicallycaptured at the distal end portion of the second elongated member 108 byinserting the coupler 2210 into the groove 2230 in the second elongatedmember 108, and sliding the securing element 2220 upward to capture thecoupler 2210 within the slot 2225. The slot 2225 in the securing element2220 can be wide enough to allow the cutting element 2010 to extendradially outwardly therethrough, but too narrow to allow passage of thecoupler 2210. The coupler 2210 is configured to rotate within the groove2230, thereby allowing the extension angle of the cutting element 2010(relative to the second elongated member 108) to vary. The width of theslot 2225 may be varied to allow a varied range of motion of the coupler2210 (and thus the cutting element 2010) in the groove 2230 when thetreatment assembly 100 is expanded. In FIG. 22C the groove 2230 is shownextending proximally beyond the securing element 2220, but in otherembodiments the groove 2230 may terminate at more distal locations(including aligned with or distal to a proximal terminus of the securingelement 2220). In some embodiments, the coupler 2210 is fixed within thegroove 2230 such that it cannot rotate relative to the second elongatedmember 108.

The second elongated member 108 can have a tapered distal tip 2020 atits distal end. The tapered distal tip 2020 is removed from view in FIG.22B to show the coupler 2210 in the groove 2230, but shown in FIG. 22Cto illustrate how the coupler 2210 and cutting element 2010 aremechanically captured. The distal tip 2020 can prevent distal axialmovement of the securing element 2220 and the coupler 2210, therebysecuring the coupler 2210 within the slot 2225 in the securing element2220. In some embodiments, the distal tip 2020 has a maximum diameterthat is greater than the diameter of the second elongated member 108. Insome embodiments, the coupler 2210 is secured within the slot 2225 viaother means, such as a non-tapered distal cap, tube, or other componentto prevent securing element from sliding out of the slot 2225. In theseand any embodiments disclosed herein, the second elongated member 108can have a lumen 22 extending therethrough. The distal tip 2020 can alsoinclude a lumen that is an extension of lumen 22.

The securing element 2220 and/or second elongated member 108 can includeone or more securing means so that when the securing element 2220 is inposition over the coupler 2210, the axial and rotational position of thesecuring element 2220 (and thus axial position of the coupler 2210) isfixed relative to the second elongated member 108. For example, thesecuring element 2220 may have one or more side holes (not shown) andthe second elongated member 108 may have one or more protrusions thatspring radially outwardly into the side holes when the side holes arealigned with the protrusions. In some embodiments, the securing element2220 includes one or more tabs (not shown) which can be pushed radiallyinward to lock into one or more receptacles in the second elongatedmember 108. Additionally or alternatively, the securing element 2220 canbe soldered, welded, or glued to the second elongated member 108 to holdthe securing element 2220 in place.

The proximal end portion 2010 a of the cutting element 2010 may bemechanically captured at a distal portion of the first elongated member111. For example, the first elongated member 111 may include a groovesimilar to the slot 2225 on the securing element 2220. In suchembodiments, the second elongated member 108 can have a recess in itsouter surface so that the second elongated member 108 can rotate freelywith respect to the first elongated member 111 to expand and collapsethe cutting element(s) 2010. As previously mentioned, in someembodiments the cutting element 2010 is integral with and an extensionof the first elongated member 111.

The coupler 2210 can have other shapes and configurations. For example,in some embodiments the distal end portion 2010 b of the cutting element2010 may be cut (e.g., laser cut) to have a T-shaped distal end that isconfigured to be received within the slit 2225 of the securing element2220. The T-shaped distal end (or portion thereof) is then trapped inplace between the securing element 2220 and the second elongated member108. The treatment assembly 100 can include a distal tip to secure theT-shaped distal end in place.

In any of the embodiments including one or more cutting elements 2010,the treatment assembly 100 may optionally include an expandable member(e.g., a balloon) (not shown) disposed radially inwardly of the cuttingelement 2010. The expandable member can be configured to be expandedunderneath the already-expanded (partially or completely) cuttingelement 2010 to add radial force to the cutting element 2010 and preventor reduce distortion of the cutting element 2010 as the treatmentassembly 100 is translated and/or rotated through the treatment site.The expandable member may be aligned with only the intermediate and/ordistal portions of the cutting element 2010 (i.e., and not the proximalportion), so as not to interfere with the cutting action of the cuttingelement 2010 on the proximal aspect of the treatment assembly 100.

In some embodiments, for example as shown in FIGS. 23A and 23B, thetreatment device includes an elongated shaft 102 comprising first andsecond elongated members 111, 108 and a cutting portion 300. The firstelongated member 111 comprises an elongated tube 2320, a distal band2330, and two or more strips 2350 connecting the proximal tube 2320 tothe distal band 2330. In a collapsed state, the strips 2350 may beparallel to the axis of the elongated shaft 102, or may be at a slightangle (e.g., between 0 and 20 degrees) from the axis of elongated shaft102 (as shown in FIG. 23A). The second elongated member 108 can beconfigured to be slidably disposed within a lumen of the first elongatedmember 111. The second elongated member 2003 can extend through theproximal tube 2320 and the portion underlying the strips 2350, anddistally beyond the distal band 2330. The treatment assembly 100 cancomprise a distal tip 2020 coupled to the distal end of the secondelongated member 2003 that has a maximum diameter larger than thediameter of the distal band 2330. In some embodiments, the distal tip2020 is locked to the distal band 2330 of the first elongated member 111by means of locking elements on the second elongated member 108 anddistal band 2330. For example, the distal band 2330 can have side holesand the second elongated member 108 may have protrusions that springoutwards into the side holes. In some embodiments, the distal band 2330has tabs which can be pushed radially inward to lock into receptacles inthe second elongated member 108. Additionally or alternatively, thesecond elongated member 108 and distal band 2330 can be attached, forexample, via welding, glue, or soldering.

In any case, when the second elongated member 108 is pulled proximally,the distance between the distal band 2330 and the distal end of theproximal tube 2320 shortens and the strips 2350 on the first elongatedmember 111 bow radially outwardly to form expanded arms, as shown inFIG. 23B. In those embodiments where the strips 2350 are attached to thefirst elongated member 111 at an angle (as shown in FIGS. 23A and 23B),the arms are somewhat twisted in the plane perpendicular to theelongated shaft 102. The strips 2350 might have one or more edges thatare sharpened and/or serrated. When expanded, the treatment assembly 100may be rotated and/or translated to act as rotary blades to removeobstructive material from the treatment site. The amount of expansiondepends on the amount of translation of the second elongated member 108relative to the first elongated member 111. In use, the arms may bepartially extended outwards for a first pass, and then further expandedfor a second pass, etc., to remove obstructive material moreeffectively.

The strips may be integral to the first elongated member 111. As seen inFIG. 23A, the first elongated member 111 can be cut (e.g., laser cut) tocreate one or more strips, parallel to or at a slight angle to the axisof the elongated shaft 102. Optionally the cut pattern includes recessedportions 2360 along the length of one, some, or all of the strips 2350to urge the strip 2350 to preferentially bend at the recessed portions2360. The recessed portions 2360 may be at the midpoint of the strip2350, to create a symmetric expanded geometry, or may be biased towardsthe distal end of the strip 2350 to create an asymmetrical expandedgeometry, as illustrated in FIG. 24. The latter configuration may allowfor a better cutting angle of the strip cutting edge against theobstructive material.

In some embodiments, the strips 2350 are not the cutting element.Instead, as seen in FIG. 25, the strips 2350 contain tabs or otherfeatures that allow a second cutting element, such as a blade 1010, tobe attached to each strip 2350. In this variation, the first elongatedmember 111 may be made from one material that is configured to beexpanded and collapsed, and the blade 1010 may be made from a secondmaterial that is suited to have a sharpened blade edge. The blade 1010may be secured to strips 2350 by means of a separate latch component(not shown). Additionally or alternatively, the blade 1010 may besoldered or welded to the strip 2350.

In some instances, it may be desirable to have an additional cuttingelement orientated in the opposite direction of the existing cuttingelement to provide a counter-force during cutting of obstructivematerial. For example, in some embodiments the device may include one ormore inner cutting elements (such as cutting element 2010) positionedinside one or more outer cutting elements (such as cutting element2010). The inner cutting elements can be substantially linear (forexample as shown in FIG. 23) or may be helical and/or spiral (forexample as shown in FIGS. 20A and 20B). The outer cutting elements canbe substantially linear (for example as shown in FIG. 23) or may behelical and/or spiral (for example as shown in FIGS. 20A and 20B). Insome embodiments, the device 101 may comprise an inner elongated member108, an outer elongated member 111 with one or more cutting element(s)2010, and an elongated member located between the inner and outerelongated members 108, 111 that comprises one or more cutting elements.In such embodiments, the cutting elements can be integral to the outerand intermediate elongated members, or may be separate elements attachedto the outer and intermediate elongated members. The handle 12 of thedevice 101 (FIG. 1) may have an actuator that controls the rotationalmovement of the outer and middle elongated members. For example, anactuator(s) on the handle 12 may be configured to turn the outerelongated member 111 in one direction while either keeping the innercutting element (carried by the intermediate elongated member)stationary or rotating the inner cutting element in the oppositedirection. In some embodiments, for example as shown in FIG. 26, acutting portion 300 of the treatment assembly 100 comprises an innerelongated member 108, an outer elongated member 111 with one or moreattached or integral cutting elements 2010, and an intermediate member2323 located between the inner elongated member 108 and the outerelongated member 111, with corresponding cutting elements 2326 (labeledindividually in FIG. 26 as 2326 a-2326 d). In such embodiments, thehandle 12 (FIG. 1) can include one or more actuators to rotate the outerelongated member 111 in one direction with respect to the innerelongated member 108 while shortening the intermediate elongated member2323 to expand the cutting elements 2326 radially outwardly duringdeployment. The handle 12 can be configured to further actuate the outerand intermediate elongated members 111, 2326 to rotate and/or translateto cut the obstructive material. One, some, or all of the cuttingelements 2010 can have a sharpened edge, and one, some, or all of thecutting elements 2326 can have a sharpened edge. In some embodiments,only the outer cutting elements 2010 or only the inner cutting elements2326 may have a sharpened edge. In those embodiments including inner andouter cutting element(s) with sharpened edges, the sharpened edges canbe configured to face each other. As such, the inner and outer cuttingelements 2326, 2010 can be configured to trap obstructive material asthey move towards one another to cut the obstructive material. The innerand outer cutting elements 2326, 2010 can thus provide a counterforce tothe cutting force (or any force) exerted on the obstructive material bythe other.

In a similar fashion, the embodiment shown in FIGS. 23A and 23B couldhave one or more expandable cutting elements located inside the outercutting elements. The treatment assembly 100 can have an intermediateelongated member located between the inner elongated member 108 and theouter elongated member 111, with corresponding expandable cuttingelements. The inner and outer cutting elements could be configured suchthat when expanded, the cutting edges of the inner cutting elements arecanted in one direction and the cutting edges of the outer cuttingelements are canted in the opposite direction. As above, the handle 12can have an actuator that controls the rotational movement of the outerand intermediate elongated members. For example, the handle 12 may beconfigured to turn the outer elongated member 111 in one direction whileeither keeping the intermediate member stationary or rotating theintermediate member in the opposite direction.

In some embodiments, the cutting portion 300 can be configured asprovided in FIGS. 27A-27D. In such embodiments, the cutting portion 300can be made from a superelastic tube such as nitinol or others, with acut pattern than forms multiple (2 or more) arms 1502 protruding fromthe distal end of the nitinol tube. The arms 1502 can be heat-set toexpand outward in a larger diameter than the base tube once a sleeve 112is retracted. One, some, or all of the arms 1502 can be shape set toassume the shape shown in the side views of FIGS. 27C and 27D. As shownin FIG. 27C, the arm 1502 can have a first substantially linear portion1502 a extending from the tube, a second portion 1502 b extendingdistally and radially outwardly from the first portion 1502 a, and athird, distal-most portion 1502 c extending distally and radiallyinwardly from the second portion 1502 b. The curve between the secondand third portions 1502 b, 1502 c forms an atraumatic surface that canslide along the vessel wall. In such embodiments, the cutting element302 can project distally from the distal terminus 1504 of the arm 1502and along a dimension that is substantially parallel to the vessel axisand along the direction of movement of the arm 1502 (indicated by arrowA). In some embodiments, for example as represented by FIG. 27D, one,some, or all of the arms 1502 include a fourth portion 1502 d extendingdistally from the third portion 1502 c along a dimension that issubstantially parallel to the vessel axis and along the direction ofmovement of the arm 1502 (indicated by arrow A).

One, some, or all of the arms 1502 can have a beveled and sharpenedpoint. Like the cutting portion 300 in FIGS. 8-9B, the cutting portionsin the embodiments represented by FIGS. 27A-27D form a circumferentialpattern, although since the blades do not overlap in the collapsedconfiguration, the cuts will not be as close together. However, becausethey are not required to overlap in the collapsed configuration, thecollapsed profile takes up less space, which can be advantageous for anendovascular device.

FIGS. 28A and 28B are isometric views of a cutting portion configured inaccordance with several embodiments of the present technology. FIG. 28Ashows the cutting portion in a collapsed state. FIG. 28B shows thecutting portion in an expanded state. The system 10 and/or assembly 100of FIGS. 28A and 28B can be generally similar to the system 10 and/orassembly 100 of FIGS. 27A-27D, except in FIGS. 28A and 28B, the system10 includes a cover 1600 positioned over all or a portion of the cuttingportion 300. The cover 1600 can be a braid, a weave, a fabric, a polymermaterial, etc.

C. Example Methods of Use

Various approaches may be used to gain intravascular access to theobstructive material within the vessel lumen. In some embodiments, themethod includes percutaneously accessing the blood vessel lumen (such asa vein) with a guidewire, advancing the introducer sheath (such as anyof the introducers disclosed herein) over the guidewire and through theaccess site, and inserting a treatment device (such as any of thetreatment devices disclosed herein) through a lumen of the introducersheath into the blood vessel lumen. The distal portion of the treatmentdevice containing the treatment assembly can be advanced to a targettreatment site within the vessel lumen. The access site can be at, forexample, a femoral vein, an internal jugular vein, or a popliteal vein.In some embodiments the method includes aspirating or infusing athrombolytic agent into or from the blood vessel before, during, orafter extraction of the obstructive material.

In some embodiments, a guidewire may first be inserted into the bloodvessel lumen and advanced through the obstructive material such that adistal terminus of the guidewire is distal of the obstructive material.Next, the introducer 103 (FIG. 1) may be delivered over the guidewire sothat a distal portion of the introducer 103 (FIG. 1) is positionedwithin the vessel lumen proximal of the obstructive material. In thoseintroducer 103 embodiments which include a funnel at the distal end ofsheath 110, the funnel 700 be expanded into apposition with the bloodvessel wall. The method can continue by inserting the treatment device101 over the guidewire, through the introducer 103, and into the vessellumen. In some embodiments, the treatment device 101 can be advancedthrough the obstructive material such that some or all of the treatmentassembly 100 of the treatment device 101 is distal of the obstructivematerial. In some embodiments, the treatment assembly 100 can beadvanced to a location in the vessel such that some or all of thetreatment assembly 100 is proximal of the obstructive material.

According to some embodiments, the treatment assembly 100 may becontained within the sleeve 112 during delivery. Once the distal portionof the treatment device 101 is positioned at a desired location relativeto the obstructive material at the treatment site, the sleeve 112 of thedevice 101 can be pulled proximally relative to the treatment assembly100 (or the treatment assembly pushed distally relative to the sleeve112) to release one or both of the cutting and capture portions of thetreatment assembly 100, thereby allowing the capture portion 200 and/orcutting portion 300 to self-expand. In some embodiments, the treatmentassembly 100 may be expanded distal of the obstructive material suchthat no portion of the capture portion 200 and no portion of the cuttingportion 300 engages the obstructive material during and/or immediatelyafter expansion. In some embodiments, at least a portion of one or bothof the capture portion 200 and the cutting portion 300 self-expandwithin the obstructive material. In some embodiments, the captureportion 200 is distal to the obstructive material and the cuttingportion 300 is proximal to the obstructive material. As describedelsewhere herein, in some embodiments one or both of the capture portion200 and the cutting portion 300 are not self-expanding and requiremechanical actuation.

While the capture and cutting portions 200, 300 are in an expandedconfiguration, the cutting portion 300 can be pushed towards the captureportion 200 and/or the capture portion 200 can be pulled distallytowards the cutting portion 300 (either serially, simultaneously or backand forth). Alternately, the capture and cutting portions 200 and 300can be pulled in a proximal direction to simultaneously or serially cutand capture the obstructive material. Before, during, or after suchmovement, the entire treatment assembly 100 can be pushed distally orpulled proximally towards the sheath 110. As the assembly 100 and/ordevice 101 is pulled proximally, the blades 302 of the cutting portion300 cut through the obstructive material in a direction generallyparallel to the longitudinal axis of the blood vessel, therebyseparating the obstructive material from the vessel wall and/or otherobstructive material. The capture portion 200 collects the separatedobstructive material and is then pulled into the sheath 110 for removalfrom the patient. As previously mentioned, in some embodiments thesystem 10 does not include an introducer sheath. In embodiments with afunnel 700 on the distal end of sheath 110, the funnel helps to captureall the obstructive material as the treatment device is pulled into thesheath and from them out of the of the blood vessel. In embodiments withaspiration capabilities, aspiration can be applied to one, some or allof the elongated shafts associated with the treatment system (e.g., thesheath 110, the sleeve 112, the outer member 111, etc.) to reduce thechance of embolic complications.

As previously mentioned, both the capture portion and the cuttingportion may be self-expanding, so that when the sheath is retracted, thecapture and cutting portions self-expand into the expanded state.Additionally or alternatively, the capture portion and/or the cuttingportion may be expanded by active actuation. For example, one or both ofthe capture portion 200 and the cutting portion 300 may be coupled to anactuation member that, when actuated by the operator (via a handle at aproximal portion of the treatment device 101), causes the captureportion 200 and/or the cutting portion 300 to partially or fully expand.For example, in some embodiments the treatment device includes anactuation member that is coupled to a distal end region of acorresponding one of the capture portion 200 or cutting portion 300 andwhen pulled, shortens the length of that component which has the effectof expanding that component. In those embodiments where the captureportion 200 and the cutting portion 300 are integrated within a singleexpandable component, a single actuation member may cause both to expandand/or collapse together. Likewise, in those embodiments where thecapture portion 200 and the cutting portion 300 are separate components,a single actuation member may cause both to expand and/or collapsetogether. In some embodiments where the capture portion 200 and thecutting portion 300 are separate components, each of the capture portion200 and the cutting portion 300 may be independently actuatable, whetherby separate actuation members or by different mechanisms or timings viathe same actuation member.

According to various embodiments, one of the capture portion 200 or thecutting portion 300 is self-expanding and the other of the captureportion 200 or the cutting portion 300 requires active expansion. Forexample, the capture portion 200 can self-expand when the sheath isretracted, while the cutting portion 300 requires expansion with anactuation member. In this example, the cutting portion 300 may beexpanded for only the first portion of the thrombus removal step tofacilitate initial removal of the thrombus from the wall, but is thenretracted during the remainder of the thrombus removal step as it is nolonger needed.

According to several embodiments, the treatment assembly 100 of thetreatment device 101 is positioned distal to the obstructive material,expanded, and then manipulated such as rotated, translated, or both, toseparate obstructive material from the wall. For example, the treatmentassembly can comprise one or more cutting elements (FIGS. 20A, 20B, 21A,etc.), and the inner elongated member is rotated to expand the cuttingelement to some or all of its expansion amount, and then manipulated toseparate obstructive material from the treatment site. The treatmentdevice can be readvanced for a further expansion and manipulation, insome cases to a larger expansion amount, for additional separation ofobstructive material.

At any point before, during, or after the foregoing methods, aspirationmay be applied at the treatment site to further reduce the risk ofembolization.

At any point before, during, or after the foregoing methods, thetreatment area may be flushed with or without aspiration to assist inseparating and capturing occlusive material. The flush may be appliedthrough treatment device via a fluid line connected to a flush source.Alternately, flush may be applied from the side arm of the introducersheath.

In some embodiments, both aspiration and flush may be applied to thetreatment site. For example, an aspiration source may be connected tothe treatment device and a flush source may be connected to theintroducer 103. Conversely, an aspiration source may be connected to theintroducer 103 and a flush source may be connected to the treatmentdevice 101. Alternately, both are connected to the treatment device 101,or both are connected to the introducer 103.

During separation and/or removal of obstructive material from atreatment site by the treatment assembly, the distal capture sheath maycapture and contain any material that has not been aspirated orotherwise removed by treatment device.

During or after separation and/or removal of obstructive material from atreatment site by the treatment assembly, the treatment device can beremoved from the introducer sheath 110 (FIG. 1). Aspiration appliedthrough the introducer sheath 110 can reduce embolic particles duringdevice removal. Inclusion of a funnel on the introducer sheath 110 mayalso reduce the possibility of embolic particles remaining in thevasculature as the treatment device is removed.

At any point before, during, or after engagement of the cutting elementswith the obstructive material, the treatment device and/or treatmentassembly can be configured to deliver energy at the treatment site. Forexample, the treatment device and/or treatment assembly may beconfigured to vibrate and/or emit ultrasonic energy.

CONCLUSION

Although many of the embodiments are described above with respect tosystems, devices, and methods for retrieving clot material from a bloodvessel lumen, the technology is applicable to other applications and/orother approaches, such as removal and/or modification of otherstructures within any body lumen. Moreover, other embodiments inaddition to those described herein are within the scope of thetechnology. Additionally, several other embodiments of the technologycan have different configurations, components, or procedures than thosedescribed herein. A person of ordinary skill in the art, therefore, willaccordingly understand that the technology can have other embodimentswith additional elements, or the technology can have other embodimentswithout several of the features shown and described above with referenceto FIGS. 1-28B.

The descriptions of embodiments of the technology are not intended to beexhaustive or to limit the technology to the precise form disclosedabove. Where the context permits, singular or plural terms may alsoinclude the plural or singular term, respectively. Although specificembodiments of, and examples for, the technology are described above forillustrative purposes, various equivalent modifications are possiblewithin the scope of the technology, as those skilled in the relevant artwill recognize. For example, while steps are presented in a given order,alternative embodiments may perform steps in a different order. Thevarious embodiments described herein may also be combined to providefurther embodiments.

As used herein, the terms “generally,” “substantially,” “about,” andsimilar terms are used as terms of approximation and not as terms ofdegree, and are intended to account for the inherent variations inmeasured or calculated values that would be recognized by those ofordinary skill in the art.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

I/We claim:
 1. A device for modifying and/or removing obstructivematerial from a lumen of a blood vessel, the device comprising: anelongated member having a proximal portion and a distal portionconfigured to be intravascularly positioned at a treatment site in ablood vessel adjacent obstructive material; a cutting portion disposedat the distal portion of the elongated member, the cutting portionincluding a cutting element, wherein the cutting portion has acollapsed, low-profile state for delivery to the treatment site and adeployed state for cutting obstructive material at the treatment site,and wherein the cutting element extends radially away from thelongitudinal axis of the elongated member in the deployed state; and acapturing portion disposed at the distal portion of the elongatedmember, wherein the capturing portion is configured to collectobstructive material that has been dislodged by the cutting portion. 2.The device of claim 1, wherein the capturing portion is positioneddistal of the cutting portion along the elongated member.
 3. The deviceof claim 1, wherein the capturing portion is self-expandable.
 4. Thedevice of claim 1, wherein the elongated member comprises a firstelongated member and a second elongated member, and wherein the cuttingportion is disposed at a distal portion of the first elongated memberand the capturing portion is disposed at a distal portion of the secondelongated member.
 5. The device of claim 4, wherein the first and secondelongated members are configured to rotate and/or translate relative toone another.
 6. The device of claim 4, wherein the second elongatedmember is configured to be slidably disposed within a lumen of the firstelongated member.
 7. The device of claim 4, wherein the first elongatedmember is configured to be slidably disposed within a lumen of thesecond elongated member.
 8. The device of claim 1, wherein the cuttingportion comprises a blade disposed along a portion of the cuttingelement.
 9. The device of claim 8, wherein the blade is disposed alongonly a proximally facing surface of the cutting element.
 10. The deviceof claim 1, wherein a cutting edge of the cutting element issubstantially linear.
 11. The device of claim 1, wherein the cuttingelement wraps around a longitudinal axis of the shaft.
 12. The device ofclaim 1, wherein the cutting element is a first cutting element and thedevice further comprises a second cutting element that is configured toextend radially away from the longitudinal axis of the elongated shaftin the deployed state.
 13. The device of claim 12, wherein an anglebetween the first and second cutting elements in the deployed state isless than 180 degrees.
 14. The device of claim 12, wherein an anglebetween the first and second cutting elements in the deployed state isfrom about 135 degrees to about 180 degrees.
 15. The device of claim 1,wherein the capturing portion and the cutting portion are independentlydeployable.
 16. The device of claim 1, wherein the capturing portioncomprises has a closed distal end portion and an open proximal endportion.
 17. The device of claim 1, wherein the capturing portioncomprises a mesh.
 18. The device of claim 1, wherein the capturingportion has a first region comprising a braid and a second regioncomprises a stent.
 19. The device of claim 1, wherein, in a deployedstate, the cutting element has a proximally facing portion and adistally facing portion, and wherein a sharpened edge of the cuttingelement is disposed along only the proximally facing portion.
 20. Thedevice of claim 1, wherein, in a deployed state, the cutting element hasa proximally facing portion and a distally facing portion, and wherein asharpened edge of the cutting element is disposed along only thedistally facing portion.
 21. A device for modifying and/or removingobstructive material from a lumen of a blood vessel, the systemcomprising: a first elongated member having a proximal portion and adistal portion configured to be intravascularly positioned at atreatment site in a blood vessel adjacent obstructive material, whereinthe first elongated member defines a lumen extending therethrough; asecond elongated member having a proximal portion and a distal portionconfigured to be intravascularly positioned at the treatment site,wherein the second elongated member is configured to be rotatablydisposed within the lumen of the first elongated member; a cuttingelement configured to cut obstructive material at the treatment site,the cutting element having a proximal end region at the distal portionof the first elongated member and a distal end region at the distalportion of the second elongated member, wherein rotation of the secondelongated member relative to the first elongated member, or vice versa,causes the cutting element to expand away from a longitudinal axis ofthe second elongated member.
 22. The device of claim 21, wherein thecutting element wraps at least partially around the longitudinal axis ofthe second elongated member as it extends between the first elongatedmember and the second elongated member.
 23. The device of claim 21,wherein the cutting element is a ribbon.
 24. The device of claim 21,wherein the cutting element has longitudinally extending edges, andwherein one or both longitudinally extending edges are sharpened. 25.The device of claim 21, wherein the cutting element has a proximallyfacing longitudinal edge and a distally facing longitudinal edge, andwherein only one of the proximally facing or distally facinglongitudinal edge is sharpened.
 26. The device of claim 21, wherein thecutting element is a first cutting element and the device comprises asecond cutting element.
 27. The device of claim 26, wherein the secondcutting element is positioned radially inwardly of the first cuttingelement.
 28. The device of claim 26, wherein the second cutting elementis positioned radially outwardly of the first cutting element.
 29. Thedevice of claim 26, wherein the second cutting element is substantiallylinear.
 30. The device of claim 26, wherein the second cutting elementwraps at least partially around the longitudinal axis of the secondelongated member.
 31. The device of claim 26, further comprising a thirdelongated member positioned between the first and second elongatedmembers, and wherein the second cutting element is at a distal portionof the third elongated member.